Alvotech is a global biopharmaceutical company dedicated to become one of the leaders in the biosimilar monoclonal antibody market. Alvotech is an independent sister company of the international pharmaceuticals company Alvogen. The company is headquartered in Reykjavik, Iceland, and has an increasingly global presence and a broad network of partners around the world. Alvotech has six key biosimilar molecules in development and a new state-of-the-art manufacturing plant for development and commercial supply. Alvotech is investing over $500 million in the development of its pipeline and facility. As a company with a global presence Alvotech offers you an exciting, creative work environment with excellent development opportunities and a long-term perspective. Within Alvotech Switzerland we are currently recruiting a
Global Drug Regulatory Affairs Manager CMC
We are currently looking for a Global DRA Manager CMC, to strengthen the Regulatory Affairs department to achieve the company goals. The main goal of Regulatory Affairs at Alvotech is to lead and coordinate all regulatory affairs activities concerning the global development, global registration and maintenance of approvals of the biosimilar products.
Most important task of the job:
Manage all CMC regulatory aspects of biosimilars development, global registration and
maintenance of assigned products with high quality, ensuring regulatory compliance
Define CMC regulatory strategies for assigned development projects.
Assure that assigned products from a CMC perspective are developed in line with global
regulatory requirements of all target countries.
Represent regulatory affairs in cross-functional project team.
Lead cross-functional regulatory projects (e.g. briefing documents, CTAs, INDs) in a
proactive, engaging and efficient way, together with co-development partners.
Consult and inform line manager of status, issues, risks, and proposed solutions as
appropriate timely and appropriately
Compilation of presentations and reports to line manager and management functions
Lead interactions with partners for specific responsibility
Organisation Structure:
Global DRA Manager reports to Vice President Global Regulatory Affairs Biologics.
Prerequisite: The Global DRA Manager will be based in the Basel area, with assignments to Reykjavik on a need basis. Will likely be required to travel every 6-8 weeks, either to Reykjavik (Alvotech headquarters) or to partners.
Qualification and Experience:
Education: University Degree in Pharmacy, Chemistry, Biology, Biotechnology or equivalent, PhD preferred.
Experience: 3 - 5 years of experience in EU and/or US or Global CMC regulatory affairs for biologics, ideally monoclonal antibodies, allowing to develop proactive global biosimilar strategies. Experience with writing and establishing briefing documents for multiple health authorities, writing, submission and approval of CTA and IND, MAA and BLA, ideally also other global submissions. This role requires excellent communication, team work and collaboration skills combined with strong prioritization skills. We are looking for open minded personalities with regulatory affairs capabilities, which are interested in biosimilar development and want to be part of a highly diversified and challenging environment at Alvotech.
We offer:
In response to our innovative and stimulating atmosphere of a multicultural and demanding environment, we offer opportunities to bring forward ideas, lead change as well opportunities for personal development and growth in an international company.
Should you be interested, please send your complete curriculum vitae in English, references (including certificates, both in one pdf - document), salary expectations, and your earliest possible starting date by applying online to Jozefina Mijatovic (Ms.): jozefina.mijatovic@alvotech.com.
Join our team and growth at Alvotech!